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Press Release Neurotech Granted Fast Track Designations from the FDA for NT-501 in Two Indications—Retinitis Pigmentosa and Dry Age-Related Macular Degeneration Lincoln, RI (September 3, 2008) - Neurotech Pharmaceuticals, Inc., a privately-held biotechnology company focused on the development of sight-saving therapeutics for chronic retinal diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designations for NT-501 for the treatment of visual loss in two indications?retinitis pigmentosa (RP) and the dry form of age-related macular degeneration (dry AMD). NT-501 is an intraocular, cell containing polymer implant designed to provide continuous, long-term release of the therapeutic protein Ciliary Neurotrophic Factor (CNTF) directly into the back of the eye by means of the Company's proprietary Encapsulated Cell Technology. CNTF, a well established neurotrophic factor, rescues dying retinal photoreceptors and protects them from degeneration. "We remain on track to announce top line results from our two Phase 2/3 studies in RP and our Phase 2 study in dry AMD by early 2009," said Ted Danse, President and CEO of Neurotech. "The receipt of Fast Track designations for NT-501 in these indications is an important component in our ongoing product development strategy, allowing us to potentially accelerate our two clinical development programs as we seek to provide much needed treatment options for patients facing these devastating diseases." The Fast Track program, established under the FDA Modernization Act of 1997, provides for expedited regulatory review of a drug that demonstrates the potential to address an unmet medical need for the treatment of serious or life-threatening conditions. Under the program, the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product, including potentially accepting, on a rolling basis, portions of the marketing application for review prior to the completion of the final registration package. About Neurotech's Clinical Programs Phase 2/3 Studies in Retinitis Pigmentosa (RP) Phase 2 Study – Dry Age-related Macular Degeneration (Dry AMD) About the Diseases Age-related macular degeneration (AMD) is a chronic progressive disease of the macula that results in the loss of central vision. It is the leading cause of blindness in elderly people in the developed world. There are two forms of AMD-dry and wet. Dry AMD is the most common form of AMD representing approximately 90% of all AMD cases. In its later stages dry AMD can lead to the degeneration of photoreceptors and retinal pigment epithelial cells, a chronic condition called geographic atrophy (GA). GA affects approximately 1 million people in the United States for which there currently are no effective treatments. About Encapsulated Cell Technology About Neurotech Pharmaceuticals, Inc. |
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